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The objective is to determine if how physical fitness, measured using a treadmill maximal oxidative capacity test, is associated with the capacity to metabolize a high-fat meal in pediatrics (ages 8-17 years). Ability to metabolize the meal will be assessed by profiling mitochondrial and extra-mitochondrial fatty acid metabolites. The investigators will test if fatty acid oxidation mediates the relationship between fitness and markers of metabolic health, such as insulin resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-fat Metabolic Challenge | Experimental | Participants will consume a high-fat agent one time, at the second study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-fat Challenge | Dietary Supplement | The shake will be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor. |
| Measure | Description | Time Frame |
|---|---|---|
| Palatability of the High Fat Agent. | Determine the number of participants that complete at least 75% of the shake (by weight). | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| BMI Percentile | BMI percentile calculated for each participant. Average and standard deviations were reported. | At baseline |
| Medium Chain Acylcarnitine Concentration | Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Health | Lebanon | New Hampshire | 03766 | United States |
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No pre-assignment occurred.
Enrollment was completed in September 2022 (n=15). Recruitment followed D-H IRB approval. Adolescents (8-17 years) were recruited through the Children's Hospital at Dartmouth Hitchcock (assisted by Dr. Susanne Tanski), the Weight and Wellness Center (assisted by Dr. Auden McClure), and, as needed, through the community. Flyers have been developed by DHMC marketing.
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| ID | Title | Description |
|---|---|---|
| FG000 | High-fat Metabolic Challenge | All participants consumed a high-fat agent at the second study visit. The shake was be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-fat Metabolic Challenge | Participants will consume a high-fat agent one time, at the second study visit. High-fat Challenge: The shake will be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Palatability of the High Fat Agent. | Determine the number of participants that complete at least 75% of the shake (by weight). | Posted | Count of Participants | Participants | 10 minutes |
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Adverse events were collected from signing the consent document to 2 weeks post the high-fat challenge study visit. Participants concluded the study at this timepoint.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-fat Metabolic Challenge | All participants consumed the high-fat challenge |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Meijer | Happy Trails Nutrition | 6036505250 | jen@htnutrition.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2023 | Jul 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| 60 and 180 minutes post consumption of high fat shake |
| Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes. | Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported. | 60 and 180 minutes post consumption of high fat shake |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Secondary | BMI Percentile | BMI percentile calculated for each participant. Average and standard deviations were reported. | Posted | Mean | Standard Deviation | percentile | At baseline |
|
|
|
|
| Secondary | Medium Chain Acylcarnitine Concentration | Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported. | Posted | Mean | Standard Deviation | mircoM | 60 and 180 minutes post consumption of high fat shake |
|
|
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| Secondary | Fold Change of Medium Chain Acylcarnitine at 60 and 180 Minutes. | Medium chain acylcarnitines profiled in the plasma include acylcarnitine 6:0, 8:0, 10:0, 10:1, 12:0, and 12:1. Medium chain acylcarntine concentration was averaged in each participant. Average and standard deviations were reported. | Posted | Mean | Standard Deviation | ratio | 60 and 180 minutes post consumption of high fat shake |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |